- Merck & Co. (Rahway, NJ)
- …that delivers high quality data and clinical supplies. - The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global ... related to quality assurance, quality systems , auditing, quality management systems or other GMP compliance activities. - Experience with Veeva… more
- Merck & Co. (Rahway, NJ)
- …Auditing, Quality Assurance Inspection, Quality Control Inspection, Quality Management , Quality Management Systems (QMS), Quality ... investigate, and resolve trends. Report results to Divisional and Regional Quality / Management councilsProvide guidance and consultation services for regulatory… more
- Novo Nordisk Inc. (Durham, NC)
- …of the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems required Understanding of quality ... oversight & on floor production support required Knowledge in Quality Management Systems required Demonstrated knowledge of critical controls & input/output… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This ... guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab… more
- Merck & Co. (Durham, NC)
- …related to compliance with cGMP regulations and our Company's Quality Management System. Responsibilities include:Supporting Validation, (Re)qualification, ... quality oversight for Validation, Plant Engineering, and Deviation Management activities related to drug substance and drug product manufacturing.Position… more
- Genmab (NJ)
- …we would love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical Data ... external vendor management a plus.Proven expertise in protocol design, data quality management , and protocol deviation oversight.Strong knowledge of EDC … more
- BioAgilytix (San Diego, CA)
- …systemsFollows standard operating procedures (SOPs) including those for account management , systems configuration, change control, and incident ... The Laboratory Systems Analyst is responsible for providing support to...skillsStrong interpersonal skills to work with all levels of management and employeesStrong organizational skills to perform and prioritize… more
- Aequor (Athens, GA)
- …Utilize standard operating procedures to conduct environmental monitoring activities. Use data management systems to enter and track results. Demonstrate a ... Performs operations necessary for quality testing. Performs generally supervised, routine tasks, following...knowledge of Microsoft business office applications Experience with LIMS systems . Bachelor's Degree with a degree focused in… more
- Merck & Co. (Durham, NC)
- …for driving MPS throughout the organization to enable change in the operating systems , management systems , and mindsets, behaviors and capabilities of ... a healthier future for all of us.Our company Production Systems (MPS) is an integrated production system for how...our people to produce product at the highest quality , for the lowest cost, and in the shortest… more
- BioAgilytix (Durham, NC)
- …data integrity and compliance.Develop a roadmap for building a high-performing data management team, identifying roles in data engineering, quality , and ... That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can… more
- Aequor (Thousand Oaks, CA)
- …cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc. ... - analysis - archive) New Technology Design and Implementation: Evaluate new data management tools and technologies (eg, EDC systems , data integration platforms,… more
- Merck & Co. (Rahway, NJ)
- …years of experience with increasing responsibility in Manufacturing, Supply Chain Management , Quality , Science and Technology, Global Procurement, Market ... Management Process, Manufacturing, Microsoft Power Apps, Microsoft Teams, Quality Support, Risk Monitoring, Social Collaboration, Stakeholder Communications, Stakeholder… more
- Aequor (Waltham, MA)
- …to manage multiple complex relationships within a CMO network Experience with electronic Quality Management Systems Experience in conducting or hosting ... and preventive actions. Suggest the development, implementation, and maintenance of quality systems , processes, and procedures related to GMP operations… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …PowerPoint, Excel, OneNote, Project, and Teams Requires demonstrated computer skills with data management systems or data bases Ability to utilize electronic ... as 120 VAC, 24 VDC, 480 VAC GAMP guidelines Computer Maintenance Management Systems (CMMS) Understanding standard operating procedures (SOP's) Physical… more
- Aequor (Thousand Oaks, CA)
- …Familiarity with Adobe Creative Cloud, basic CMS workflows, and/or digital asset management systems . Certification in project management (PMP, Agile/Scrum, ... across platforms like .com and social media. They bring strong project management and content production experience, with a proactive, diplomatic communication style… more
- Novo Nordisk Inc. (Durham, NC)
- …relevant areas Own self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, ... for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive analytics and… more
- Aequor (Bothell, WA)
- …stakeholdersProvide local administrative support and liaise with global partners for site quality systems and quality control supporting applications, ... systems , Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow, and emerging technology (preferred)Professionalism and… more
- Merck & Co. (Durham, NC)
- …Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Processes, Problem Management , Process Automations, Quality Management , Real-Time ... technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement,… more
- Merck & Co. (Rahway, NJ)
- … Management Process, Manufacturing Compliance, Mechatronics, Medical Device Quality Systems , Medical Devices, Pharmaceutical Process Development, Procurement, ... for management review of the company's device quality management system, including working with sites...authoring and reviewing regulatory submissions.Experience performing gap analysis of quality systems against ISO 13485, MDSAP, EU… more
- Novo Nordisk Inc. (Durham, NC)
- …for end-users Own self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, ... for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive analytics and… more
